Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019710
Company: LIEBEL-FLARSHEIM
Company: LIEBEL-FLARSHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPTIRAY 160 | IOVERSOL | 34% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| OPTIRAY 240 | IOVERSOL | 51% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| OPTIRAY 300 | IOVERSOL | 64% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| OPTIRAY 320 | IOVERSOL | 68% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| OPTIRAY 350 | IOVERSOL | 74% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019710Orig1s067;020923Orig1s030ltr.pdf | |
| 02/18/2022 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019710Orig1s065; 020923Orig1s028ltr.pdf | |
| 05/04/2022 | SUPPL-64 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710Orig1s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019710Orig1s064ltr.pdf | |
| 01/23/2020 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019710s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019710Orig1s058ltr.pdf | |
| 04/05/2017 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s055,020923Orig1s020ltr.pdf | |
| 04/26/2017 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019710Orig1s054,020923Orig1s019ltr.pdf | |
| 05/13/2016 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019710Orig1s052,020923Orig1s018ltr.pdf | |
| 12/06/2013 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2013 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2016 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019710Orig1s039,020923Orig1s009ltr.pdf | |
| 08/08/2009 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s034ltr.pdf |
| 08/28/2007 | SUPPL-33 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019710s032ltr.pdf |
| 03/15/2006 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/02/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2001 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/16/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-21 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019710a_so21_052397.pdf |
| 01/13/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/21/1995 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/27/1993 | SUPPL-17 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-12 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/26/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1992 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/22/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1992 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/30/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/17/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019710s067,020923s030lbl.pdf | |
| 05/04/2022 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710Orig1s064lbl.pdf | |
| 05/04/2022 | SUPPL-64 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710Orig1s064lbl.pdf | |
| 02/18/2022 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019710s065,020923s028lbl.pdf | |
| 01/23/2020 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019710s058lbl.pdf | |
| 04/26/2017 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s054,020923s019lbl.pdf | |
| 04/05/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019710s055lbl.pdf | |
| 08/12/2016 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019710s039,020923s009lbl.pdf | |
| 07/06/2015 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019710s052,020923s018lbl.pdf |